Houseplant pharmaceutical company Lupin Ltd said on Tuesday it had received an Inspection Establishment Report (EIR) from the US Food and Drug Administration (USFDA) for its manufacturing facility. Goa following an inspection in September 2021 with a Voluntary Action Designation (VAI).
The USFDA has determined that the facility’s inspection classification is VAI, the company said in a statement.
Although objectionable conditions were discovered and recorded during the inspection, the agency was not prepared to take or recommend regulatory action, according to the USFDA, according to the VAI.
Commenting on this development, Vinita Gupta, CEO of Lupine said, “We are delighted to receive an EIR from the US FDA with a Voluntary Action Designation classification for our Goa plant. This is an important milestone as we rebuild our reputation of being best in class for quality and compliance.”
She added, “We are committed to producing and delivering products of the highest quality from all of our manufacturing facilities.”
Assessing the development as “very positive”, Lupine CEO Nilesh Gupta said, “Goa has a very important position in the US market for its quantity of affordable, quality medicines. that we offer, and we’re now expecting new products to flow off the site again.”
In early September this year, Lupine said the USFDA conducted an inspection at the Goa facility and closed it with seven observations. The inspection was carried out from September 6 to September 18, 2021.
https://www.ndtv.com/business/lupin-receives-eir-from-usfda-for-goa-manufacturing-facility-2650643 Lupine receives inspection report from USFDA for Goa manufacturing facility